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U.S. Department of Health and Human Services

Class 2 Device Recall Imageintensified fluoroscopic xray system, mobile

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  Class 2 Device Recall Imageintensified fluoroscopic xray system, mobile see related information
Date Initiated by Firm May 15, 2023
Date Posted July 31, 2023
Recall Status1 Open3, Classified
Recall Number Z-2277-2023
Recall Event ID 92504
510(K)Number K120613  K073543  K082781  K122234  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Product OEC 9900 Systems with 9-inch Image Intensifier
Code Information UDI-DI: 00840682114301 Serial Numbers: ES-2700, ESXXXL00081, ESXXXL00104, ES-2873, ESXXXX04525, ESXXXX04526, ESXXXX04527, E9-2573, E9XXXX03024, ESXXXX04467, ES-2768, ESXXXX03911, ESXXXX04425, E9-2510, E9-2646, ES-3208, ES-3209, ES-2934, ES-2940, ESXXXX04391, ES-0662, ES-3216, ES-3217, E9-1266, E9-2330, ESXXXX04441, E9XXXX03364, ES-1631, ES-2835, ES-2846, ES-2987, ES-3179, ESXXXX04377, ES-2692, ES-2693, ES-2847, ES-2679, E9-1695, E9-1716, E9-1719, E9-2183, E9-2186, E9-2327, E9-2328, E9-2451, E9-2517, ES-3110, ESXXXX04365, ESXXXX04369, E9-2286, E9-2571, ESXXXX04472, ES-2647, ESXXXX04436, E9-2189, ES-2755, ESXXXX04475, E9-2645, ESXXXX04449, ES-2667, ESXXXX04435, E9XXXX03408, E9-2187, ES-2868, ESXXXX04394, ES-2981, ES-2942, ES-2965, ESXXXX04505, E9-2246, ES-2988, E9XXXX03336, ES-1548, ES-2948, ESXXXX04462, E9-0975, ES-3080, ESXXXX04061, ESXXXX04497, ESXXXX04465, ESXXXX04468, ESXXXX04489, E9-2562, ES-2953, ESXXXX04464, ESXXXX04488, ESXXXX04484, ES-2808, ES-2689, ES-2848, 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ESXXXX04453, ES-2665, E9-2398, E9-2399, E9-2318, E9-2392, ES-2691, ES-3204, ESXXXL00075, ESXXXL00076, ESXXXX04439, E9-2532, ES-2635, ES-3180, ES-2914, ES-2952, ESXXXX04509, ES-2787, ESXXXL00061, E9-2298, E9-2200, E9-2557, E9-2889, ES-2825, ES-2907, ES-3135, ES-3136, ES-3137, ESXXXX04501, E9-2245, E9-2297, ES-2754, E9-2296, E9-2523, ESXXXX04521, ES-3134, ES-2660, ESXXXX04448, ES-2994, ESXXXX04482, ESXXXX04443, E9-2329, E9-2397, E9-2401, E9-2640, E9-2642, E9-2652, E9XXXX03419, E9XXXX03493, ES-2648, ES-2687, ES-2772, ES-2834, ES-2909, ES-2972, ES-3074, ES-3215, ES-7307-CMH, ESXXXX04481, ESXXXX04492, ES-2685, ESXXXX04463, E9-2210, E9-2567, ES-3193, ES-3203, ES-3167, ESXXXL00087, ES-2810, E9XXXX03365, ES-2637, ES-2893, ES-3040, E9-2639, ES-2856, E9-2393, E9-2345, ESXXXL00089, E9XXXX03437, ESXXXX04516, ES-2970, E9-2185, E9XXXX03436, E9-2521, ES-2889, ESXXXX04370, ESXXXX04490, E9-2654, E9-2496, ES-2999, ES-3285, E9-2588, ES-2682, ES-2979, ES-2630, ES-2991, E9-2568, E9-2205, ES-3083, E9-2551, 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E9-2275, E9-2274, E9XXXX03479, ES-7317-CMH, ESCMHX07465, ESCMHX07464, ES-7337-CMH, E9XXXX03495, ESCMHX07467, ESCMHX07462, ES-7326-CMH, ES-7316-CMH, ESCMHX07477, E9XXXX03468, E9XXXX03472, E9XXXX03473, E9XXXX03363, E9XXXX03469, E9XXXX03440, E9XXXX03476, E9XXXX03478, E9-2396, E9-2400, E9-2408, ES-3072-CH, E9-2570, E9-2255, E9-2253, E9-2290, E9-2288, E9-2289, E9-2294, E9-2406, E9-2501, E9-2748, ES-3069, ESXXXX04523, ESXXXX04524, ES-2985, E9-2488, E9-2261, E9-2508, ES-2891, E9-2506, E9-2500, ES-3075, E9-2507, E9XXXX03434, ES-2984, E9XXXX03426, E9-2589, E9-2838, ES-2852, E9-2560, ES-3450, ES-2870, ESXXXX04503, ES-3038, E9-2258, E9XXXX03005, E9-2262, E9XXXX03474, ESCHXX90039, ESCHXX90040, ESXXXX04380, ESXXXX04454, ESXXXX04476, ESXXXX04518, ESXXXX04520, ES-3070, E9-2533, ES-3068, ESXXXX04528, E9-2531, E9-2590, E9-2747, ES-2911, ES-3071, E9XXXX03475, ESXXXX04471, E9XXXX03359, E9XXXX03368, E9XXXX03491, E9XXXX03471, E9XXXX03415, E9XXXX03439, E9XXXX03357, E9XXXX03429, E9XXXX03470, E9XXXX03488, E9XXXX03490, E9XXXX03492, E9XXXX03494, ESXXXX04500, E9XXXX03487, E9-2317, E9XXXX03367, E9XXXX03416, E9XXXX03438, ES-7346-CMH, E9XXXX03466, E9-2257, ES-3087-CH, ESCHXX90041, E9-2302, ESCHXX90044, ESCHXX90047, ES-7325-CMH, ES-7348-CMH, ES-2977-CH, ES-1717-CH, ES-3088-CH, ESCHXX90045, ESCHXX90048, ESCHXX90046, ESCMHX07476, ESCMHX07466, E9-2279, E9XXXX03421, ESCHXX90053, ESCHXX90028, ESCHXX90052, ESCMHX07473, ESCHXX90032, ESCHXX90027, E9XXXX03459, ES-7324-CMH, E9XXXX03480, E9XXXX03481, ESXXXX04522, E9-2323, E9XXXX03417, ESCMHX07472, E9XXXX03369, E9XXXX03374, E9-2326, E9-2558, E9-2281, E9-2276, E9-2291, E9-2292, E9XXXX03486
Recalling Firm/
GE OEC Medical Systems, Inc
384 N Wright Brothers Dr
Salt Lake City UT 84116-2862
For Additional Information Contact
Manufacturer Reason
for Recall
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
FDA Determined
Cause 2
Process control
Action On 5/15/23 correction notices were mailed to: Director/Manager of Radiology, Hospital Administrator, Head of Radiology Department, PACS Administrator, Director of IT Department, Head, Biomedical Engineering, who were asked to do the following: You can continue to use your device. When transporting the device, ensure it is always in the Anterior Posterior (AP) position, as instructed in the systems Operator Manual. Use caution when moving system to avoid a large impact force. In addition, customers were asked to complete and return the acknowledgement response form to fieldactionssurgery@ge.com Customers with questions or concerns can contact the firm at 1-800-437-1171
Quantity in Commerce 908
Distribution Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Algeria, Argentina, Australia, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Burkina Faso, Canada, Chile, Colombia, Czechia, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, France, Georgia, Germany, Hong Kong, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, KOREA, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Nepal, New Caledonia, New Zealand, Nigeria, Paraguay, Peru, Poland, Portugal, Romania, Russia, Singapore, Spain, Switzerland, Taiwan, Tanzania, Thailand, Trinidad and Tobago, United Arab Emirates, United Kingdom, Uruguay, Vietnam.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = OXO and Original Applicant = GE HEALTHCARE SURGERY
510(K)s with Product Code = OXO and Original Applicant = GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC
510(K)s with Product Code = OXO and Original Applicant = GE OEC MEDICAL SYSTEMS